Medications & Supplements/Prescription Drugs

Pfizer Inc.: Fentanyl Citrate Injection Recalled for Defective Vials and Loss of Sterility

Agency Publication Date: February 10, 2020

Summary

Pfizer is recalling approximately 38,676 trays of Fentanyl Citrate Injection, USP due to a manufacturing defect where the metal overseal on the vials is loose. This defect can compromise the sterility of the medication, which is used for anesthesia and pain management. Consumers and healthcare facilities should immediately identify and isolate the affected lots to prevent patient harm. If you or a patient have used this product, contact a healthcare provider or pharmacist for guidance.

Risk

A loose metal seal on the vial may allow contaminants to enter the medication, resulting in a lack of assurance of sterility. Using a non-sterile injectable drug can lead to serious systemic infections or other life-threatening medical complications.

What You Should Do

Identify if you have Fentanyl Citrate Injection, USP 100 mcg Fentanyl/2 mL (50 mcg/mL) by checking the NDC numbers 00409-9094-12 on individual vials or 00409-9094-22 on the 25-vial trays.
Check the packaging for Lot numbers 08133DK or 08134DK on trays, or lot codes 08-133-DK or 08-134-DK on individual vials, all with an expiration date of 2/1/2021.
If you have affected products, immediately stop using them and quarantine the units to prevent further distribution or administration.
Contact your healthcare provider or pharmacist if you have concerns about medication already administered, and return any unused product to the pharmacy or place of purchase for a refund.
Contact Pfizer Inc. at 1-800-438-1985 or visit their website for specific instructions on how to return the defective product and obtain further guidance.
For additional questions or to report a safety concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL), 2 mL Single-dose Vial

Model:

NDC 00409-9094-12 (vial)

NDC 00409-9094-22 (tray)

Lot Numbers:

08133DK (tray) (Exp. 2/1/2021)

08-133-DK (vial) (Exp. 2/1/2021)

08134DK (tray) (Exp. 2/1/2021)

08-134-DK (vial) (Exp. 2/1/2021)

Date Ranges: Expiration date 2/1/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84833

Status: Resolved

Manufacturer: Pfizer Inc.

Sold By: Hospira, Inc.; Healthcare facilities; Pharmacies

Manufactured In: United States

Units Affected: 38,676 trays

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if you have Fentanyl Citrate Injection, USP 100 mcg Fentanyl/2 mL (50 mcg/mL) by checking the NDC numbers 00409-9094-12 on individual vials or 00409-9094-22 on the 25-vial trays.

Check the packaging for Lot numbers 08133DK or 08134DK on trays, or lot codes 08-133-DK or 08-134-DK on individual vials, all with an expiration date of 2/1/2021.

If you have affected products, immediately stop using them and quarantine the units to prevent further distribution or administration.

Contact your healthcare provider or pharmacist if you have concerns about medication already administered, and return any unused product to the pharmacy or place of purchase for a refund.

Contact Pfizer Inc. at 1-800-438-1985 or visit their website for specific instructions on how to return the defective product and obtain further guidance.

For additional questions or to report a safety concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.